NCT07199868

Brief Summary

Objective : This study aims to evaluate the impact of ovarian PRP therapy compared to control in Poseidon females undergoing ICSI cycles. Material and Methods: A randomized controlled trial was conducted from Jan 2024 to Feb 2025, involving 102 Poseidon women, Participants were divided into a PRP group (n=50), who received ovarian PRP injections and a control group (n=52), who received no PRP. All participants underwent ICSI cycles, embryological and pregnancy outcomes were compared between both groups within each Poseidon group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

September 9, 2025

Last Update Submit

September 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • numbers of Meta phase II oocytes and embryos post ovarian PRP

    Primary embryological outcomes including; metaphase II oocytes and embryos numbers in addition to their quality post ovarian PRP were compared in both study \& control groups

    one year

Study Arms (1)

ovarian PRP injection in poor responders

EXPERIMENTAL

During early-mid follicular phase, using TV-US guidance and conscious sedation, 1.5 ml of PRP was injected into each ovary's subcortical layer using a 17-gauge ovum pick-up needle.

Procedure: During early-mid follicular phase, using TV-US guidance and conscious sedation, 1.5 ml of PRP was injected into each ovary's subcortical layer using a 17-gauge ovum pick-up needle.

Interventions

During early-mid follicular phase, using TV-US guidance and conscious sedation, 1.5 ml of PRP was injected into each ovary's subcortical layer using a 17-gauge ovum pick-up needle.

ovarian PRP injection in poor responders

Eligibility Criteria

Age21 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • infertile Poseidon groups 2, 3, 4 women 2- no history of chronic illness or pelvic pathology. 3- All male partners were either normozoospermic or had mild OAT delivered fresh ejaculated samples for ICSI.

You may not qualify if:

  • ovarian failure due to sex chromosome abnormalities, 2- current use of anticoagulants 3- history of bleeding disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Collage of medicine

Baghdad, 00964, Iraq

Location

Collage of medicine

Karbala, 00964, Iraq

Location

MeSH Terms

Interventions

Conscious Sedation

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Itlal J AL Asadi, MD

    Department of Obstetrics & Gynecology, College of Medicine, Karbala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
non
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: During early-mid follicular phase, using TV-US guidance and conscious sedation, 1.5 ml of PRP was injected into each ovary's subcortical layer using a 17-gauge ovum pick-up needle.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 30, 2025

Study Start

January 1, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations